Cleared Traditional

K220662 - Disposable Barrier Sleeves (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K220662 · Premium Plus (Dongguan) Limited · Dental device
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May 2022
Decision
65d
Days
Class 2
Risk

K220662 is an FDA 510(k) clearance for the Disposable Barrier Sleeves. Classified as Dental Barriers And Sleeves (product code PEM), Class II - Special Controls.

Submitted by Premium Plus (Dongguan) Limited (Dongguan, CN). The FDA issued a Cleared decision on May 11, 2022 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 878.4370 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K220662 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2022
Decision Date May 11, 2022
Days to Decision 65 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 127d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PEM Dental Barriers And Sleeves
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4370
Definition Intended To Serve As A Disposable Barrier For Dental Instruments To Reduce The Risk Of Cross Contamination Between Dental Patients.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - PEM Dental Barriers And Sleeves

All 14
Devices cleared under the same product code (PEM) and FDA review panel - the closest regulatory comparables to K220662.
Dental Barrier and Sleeves
K250735 · Fomed Industries, Inc. · Jun 2025
Dental Barrier and Sleeves
K250606 · Yueying Medical Instruments (Langfang) Co., Ltd. · May 2025
Dental Barrier and Sleeves
K242435 · Wellmed Dental Medical Supply Co., Ltd. · Oct 2024
Dental Barrier and Sleeves
K233918 · Yongqing Huaguan Dental Instruments Factory · May 2024
Minitube Dentasleeve Protective Barrier Sleeves
K211026 · Minitube AB · Aug 2021